11th Annual IVD Regulatory Affairs Conference

December 5-6, 2018 | Alexandria, VA
Embassy Suites by Hilton Alexandria Old Town
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“I thought the conference was excellent!  Having a conference tailored to one discipline made each panel and contact relevant.”

Director, Compliance & Legal Affairs
Orexigen

“Great insight to hear payer perspective in contracting and account management and the changing healthcare landscape.”

Channel Liaison
Biogen

“It was definitely an excellent well-rounded opportunity to meet new people, get new ideas, and get an in-depth education on what’s to come with the FDA collaborations.”

Quality Engineer
Centurion Medical Products

“It was very well organized event and high quality, the fact to have an IVD track was also interesting. Thanks, I will recommend the Q1 event!”

Regulatory Affairs – EMEA Regional Head
BIOMERIEUX

“The organization and support staff were fantastic! I’m looking forward to next year.”

Global Business Project Lead
Genentech

About the Conference:

The Q1 Productions IVD Regulatory Affairs Conference will bring together industry leaders, as well as health authority representatives from the USA and beyond to discuss recent and impending guidance of the highest importance. With a focus on the US market in addition to an outlook on international requirements such as the impact of the IVDR in Europe, and evolving submission and clinical requirements in Asian markets, the conference ensures a holistic approach to pressing regulatory matters. Via a mix of formats including panel discussions, exchange groups, and traditional presentations, attendees have the opportunity to take away actionable content through engaging sessions and the sharing of best practices. The event will also offer a unique networking platform for delegates to connect with a multitude of key experts in the field.

Core Topics to be Addressed:

  • Regulatory submissions: Lessons learned in the management of 510k & PMA
  • Regulatory considerations in companion diagnostic partnerships with pharma
  • Best practices when navigating the uncertain regulatory environment of Asia
  • Review of CLIA waivers & opportunities for expedited regulatory pathways
  • Addressing the new IVDR classification regime & impact on the industry
  • Partnering directly with notified bodies to ensure timely IVDR accreditation
  • Proper setup of diagnostic clinical trials within an evolving regulatory environment
  • Improvement of quality initiatives with the convergence of MDSAP & ISO 13485
  • Development of robust compliance practices via post-market surveillance initiatives
  • Influence of NGS marketplace prominence on potential new FDA guidelines
  • Practical insight into achieving regulatory submission & approval of NGS tests
  • Proper methodology & collection of real world data for successful diagnostic approval
  • Opportunities in parallel review programs for regulatory approval & CMS coverage
  • Clarifying the status of impending regulation of laboratory developed tests

Audience

75 Attendees

All attendees come directly from laboratories and diagnostic companies

Distinguished Presenters

28 Speakers

with an average of 15 years experience

Networking

Networking time is built into the agenda to allow industry peers to connect and exchange ideas

Open Dialogue and Group Share

Each presentation is followed by 10-15 minutes of open dialogue for questions and exchange of best practices

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